Evaluating Two Recombinant BMP-2 Formulations in Transforaminal Lumbar Fusion: Does the Carrier Matter?

Study Design: Retrospective cohort study. Objective: To perform an exploratory comparison of clinical, radiologic, and perioperative outcomes of transforaminal lumbar interbody fusion (TLIF) using two recombinant human bone morphogenetic protein-2 (rhBMP-2) formulations, Infuse® (Medtronic, Minneapolis) and Novosis® (CG Bio, Seoul, South Korea). Summary of Background Data: Bone morphogenetic protein-2 has become a common osteoinductive agent in lumbar fusion. Infuse®, derived from Chinese Hamster Ovary cells, is effective but associated with inflammatory complications. Novosis®, an Escherichia coli –derived rhBMP-2 embedded in a hydroxyapatite/β-tricalcium phosphate carrier, potentially allows sustained protein release and lower local inflammatory response. Comparative data between these two agents in TLIF remains limited. Materials and Methods: We retrospectively reviewed patients who underwent 1- to 3-level TLIF for degenerative lumbar disorders using either Infuse® or Novosis® between 2018 and 2023. Demographics, perioperative parameters, and complications were extracted from medical records. Radiologic fusion was assessed using a six-zone scoring system at 3, 6, and 12 months. Clinical outcomes included visual analogue scale (VAS) for pain, Oswestry Disability Index (ODI), and SF-36 physical (PCS) and mental (MCS) scores. Groups were compared using t -tests or χ 2 analysis with significance at P <0.05. Further subgroup analysis was carried out using 1- and 2-level TLIF cases to evaluate if the number of levels fused affects outcomes. Results: Novosis® achieved earlier radiologic fusion (65.6% vs . 10.5% at 3 mo; P <0.001) and shorter drain duration (3.2±2.1 vs . 5.1±1.9 d; P =0.011). At 12 months, fusion rates were comparable (100% vs . 93%; P =0.162). ODI improvement favored Novosis® ( P =0.007), while SF-36 MCS improvement favored Infuse® ( P <0.001). Subgroup analysis for 1- and 2-level TLIFs did not show any significant difference in the measured outcomes. No ectopic bone formation or malignancy was observed. Conclusion: Novosis® showed earlier radiographic consolidation and a shorter drain duration, findings that may reflect carrier-specific properties, whereas Infuse® demonstrated greater mental health improvement. Overall, fusion and clinical outcomes were satisfactory with each formulation, although these observations remain exploratory and require validation in larger, prospective studies. Level of Evidence: Level III.